Department of Virology, National Institute of Laboratory Medicine and Referral Center, Dhaka, Bangladesh.
College of Graduate Studies, State University of New York Upstate Medical University, Syracuse, New York, USA.
Rev Med Virol. 2023 Jan;33(1):e2385. doi: 10.1002/rmv.2385. Epub 2022 Aug 20.
Several phase-1 clinical trials have been performed to evaluate the safety and efficacy of candidate anti-Zika vaccines. In this systematic review, we systematically evaluated the safety and immunogenicity of candidate vaccines, which would aid researchers in formulating an effective vaccination strategy for phase-2 trials based on current evidence. A literature search was conducted using the electronic databases MEDLINE through Pubmed, Web of Science, and Cochrane Database for relevant studies on candidate anti-zika vaccines. Studies on animal models were excluded from our study. Healthy individuals who were administered candidate Zika vaccines to evaluate the immune response and adverse events (AEs) compared to placebo were considered. Data were extracted, tabulated, and analysed using Microsoft Excel, while the risk of bias plots were generated using tidyverse and Robvis packages in R-studio. A total of five phase-1 clinical trials were included in our analysis comprising of studies on inactivated, viral vector, and DNA vaccines. Immunogenicity ranged from 10% to 100% after vaccination with the lowest seroconversion rate (10%) and geometric mean titre (GMT) (6.3; 95% confidence interval (CI):3.7-10.8) observed among recipients of single-dose inactivated anti-zika vaccine (ZPIV). For DNA vaccines, the seroconversion rate ranged from 60% to 100% with the highest seroconversion rate (100%) and GMT (2871; 95% CI:705.3-11688) observed among recipients of three shots of high dose GLS-5700 vaccine. For viral vector vaccine (Ad26.ZIKV.001) seroconversion rate (100%) and GMT peaked after two shots with both low and high-dose vaccines. In all those studies AEs were mostly local including injection site pain, erythema, and itching. The most common systemic AEs included fever, myalgia, nausea, and fatigue. In phase-1 clinical trials, all candidate vaccines were found to be highly immunogenic and relatively safe, especially when administered in higher doses and with the help of needle-free devices.
已经进行了几项 1 期临床试验，以评估候选抗寨卡疫苗的安全性和有效性。在本系统评价中，我们系统地评估了候选疫苗的安全性和免疫原性，这将有助于研究人员根据当前证据制定有效的 2 期试验疫苗接种策略。使用电子数据库 MEDLINE 通过 Pubmed、Web of Science 和 Cochrane 数据库进行了文献检索，以查找关于候选抗寨卡疫苗的相关研究。我们的研究排除了动物模型研究。我们考虑了接受候选寨卡疫苗以评估免疫反应和不良事件 (AE) 并与安慰剂进行比较的健康个体。使用 Microsoft Excel 提取、制表和分析数据，而使用 R-studio 中的 tidyverse 和 Robvis 包生成偏倚风险图。我们的分析共纳入了 5 项 1 期临床试验，包括对灭活、病毒载体和 DNA 疫苗的研究。接种疫苗后的免疫原性从 10%到 100%不等，在接受单次剂量灭活抗寨卡疫苗 (ZPIV) 的接种者中观察到的血清转化率最低 (10%) 和几何平均滴度 (GMT) (6.3；95%置信区间 (CI)：3.7-10.8)。对于 DNA 疫苗，血清转化率从 60%到 100%不等，在接受高剂量 GLS-5700 疫苗三剂的接种者中观察到的血清转化率最高 (100%) 和 GMT (2871；95% CI：705.3-11688)。对于病毒载体疫苗 (Ad26.ZIKV.001)，低剂量和高剂量疫苗在两针后血清转化率 (100%) 和 GMT 达到峰值。在所有这些研究中，AE 主要为局部反应，包括注射部位疼痛、红斑和瘙痒。最常见的全身 AE 包括发热、肌痛、恶心和疲劳。在 1 期临床试验中，所有候选疫苗均具有高度免疫原性和相对安全性，尤其是在高剂量给药和使用无针装置的情况下。
